NCT01384552

Brief Summary

The objective of this study is to determine the independent and combined effects of weight status and the level of dietary restraint on the relationship between package unit size and food intake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

June 25, 2011

Last Update Submit

April 3, 2018

Conditions

Overweight

Keywords

normal weightoverweightdietary restraintpackage unit sizefood intake

Outcome Measures

Primary Outcomes (1)

  • Total grams of pretzels consumed.

    Total grams of pretzels consumed by participants over the 4-day study period will be determined by subtracting pre- and post-consumption weight of snack packages provided.

    4 days

Study Arms (8)

Normal Weight, Unrestrained - Standard

ACTIVE COMPARATOR

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Standard

Normal Weight, Restrained - Single Serving

ACTIVE COMPARATOR

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Single Serving

Normal Weight, Restrained - Standard

ACTIVE COMPARATOR

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Standard

Overweight, Unrestrained - Single Serving

ACTIVE COMPARATOR

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Single Serving

Overweight, Unrestrained - Standard

ACTIVE COMPARATOR

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Standard

Overweight, Restrained - Single Serving

ACTIVE COMPARATOR

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Single Serving

Overweight, Restrained - Standard

ACTIVE COMPARATOR

Each participant is overweight (BMI: 25-39.9 kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Standard

Normal Weight, Unrestrained - Single Serving

ACTIVE COMPARATOR

Each participant is of normal weight (BMI: 18.5-24.9 kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).

Other: Package Unit Size - Single Serving

Interventions

Package Unit Size - Single ServingOTHER

Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).

Normal Weight, Restrained - Single ServingNormal Weight, Unrestrained - Single ServingOverweight, Restrained - Single ServingOverweight, Unrestrained - Single Serving
Package Unit Size - StandardOTHER

Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).

Normal Weight, Restrained - StandardNormal Weight, Unrestrained - StandardOverweight, Restrained - StandardOverweight, Unrestrained - Standard

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and females aged 18-35 years old.
  • Body Mass Index (BMI) between 18.5-24.9 kg/m2 or BMI between 25-39.9 kg/m2.
  • For normal weight groups: BMI of 18.5-24.9 kg/m2.
  • For overweight groups: BMI of 25-39.9 kg/m2.
  • Dietary restraint scores of either less than or equal to 12 or \> 12 on the Three Factor Eating Questionnaire-Cognitive Restraint scale (TFEQ-R) \[10\].
  • For unrestrained groups: less than or equal to 12.
  • For restrained groups: \> 12.
  • Do not have unfavorable preference toward pretzels.
  • Do not have allergies to pretzel ingredients.
  • Do not have a health condition or use medication that affects eating or requires a therapeutic diet.
  • Must have a consistent schedule during the time of the study.
  • Must agree to instructions to not share pretzel snack packages with others.

You may not qualify if:

  • BMI below 18.5 or above 39.9 kg/m2.
  • Have an unfavorable preference toward pretzels.
  • Have allergies to pretzel ingredients (wheat flour).
  • Severe allergies to nuts - Synder's of Hanover pretzels are made in a facility that handles peanut butter.
  • Are unwilling to consume pretzels during the time of the study.
  • Are pregnant or breastfeeding.
  • Do not meet one or more of the other above mentioned eligibility requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996, United States

Location

Related Publications (10)

  • Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

    PMID: 20071471BACKGROUND

  • French SA, Story M, Jeffery RW. Environmental influences on eating and physical activity. Annu Rev Public Health. 2001;22:309-35. doi: 10.1146/annurev.publhealth.22.1.309.

    PMID: 11274524BACKGROUND

  • Wansink B. Environmental factors that increase the food intake and consumption volume of unknowing consumers. Annu Rev Nutr. 2004;24:455-79. doi: 10.1146/annurev.nutr.24.012003.132140.

    PMID: 15189128BACKGROUND

  • Raynor HA, Wing RR. Package unit size and amount of food: do both influence intake? Obesity (Silver Spring). 2007 Sep;15(9):2311-9. doi: 10.1038/oby.2007.274.

    PMID: 17890500BACKGROUND

  • Stroebele N, Ogden LG, Hill JO. Do calorie-controlled portion sizes of snacks reduce energy intake? Appetite. 2009 Jun;52(3):793-796. doi: 10.1016/j.appet.2009.02.015. Epub 2009 Mar 6.

    PMID: 19501784BACKGROUND

  • Devitt AA, Mattes RD. Effects of food unit size and energy density on intake in humans. Appetite. 2004 Apr;42(2):213-20. doi: 10.1016/j.appet.2003.10.003.

    PMID: 15010185BACKGROUND

  • Raynor HA, Van Walleghen EL, Niemeier H, Butryn ML, Wing RR. Do food provisions packaged in single-servings reduce energy intake at breakfast during a brief behavioral weight-loss intervention? J Am Diet Assoc. 2009 Nov;109(11):1922-5. doi: 10.1016/j.jada.2009.08.009.

    PMID: 19857636BACKGROUND

  • Freedman MR, Brochado C. Reducing portion size reduces food intake and plate waste. Obesity (Silver Spring). 2010 Sep;18(9):1864-6. doi: 10.1038/oby.2009.480. Epub 2009 Dec 24.

    PMID: 20035274BACKGROUND

  • Wansink B, Payne CR, Shimizu M. The 100-calorie semi-solution: sub-packaging most reduces intake among the heaviest. Obesity (Silver Spring). 2011 May;19(5):1098-100. doi: 10.1038/oby.2010.306. Epub 2011 Jan 13.

    PMID: 21233814BACKGROUND

  • Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.

    PMID: 3981480BACKGROUND

Related Links

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hollie A Raynor, Ph.D.

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

  • Chrystal L Haire, B.S.

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2011

First Posted

June 29, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(1)